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Published in: Oral and Maxillofacial Surgery 1/2024

22-12-2022 | Lichen Planus | Research

Comparative evaluation of the efficacy of Nigella sativa (75% v/v) cream and clobetasol propionate (0.05% w/w) gel in oral lichen planus—a double-blinded randomized control trial

Authors: Lokesh Kumar S, Zameera Naik, Arun Panwar, Sridhar M, Vaishali Keluskar, Ram Surath Kumar

Published in: Oral and Maxillofacial Surgery | Issue 1/2024

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Abstract

Objectives

The a im of this study is to evaluate and compare the efficacy of Nigella sativa (75% v/v) cream and clobetasol propionate (0.05% w/w) gel for the management of oral lichen planus (OLP).

Study design

Sixty clinically diagnosed cases of OLP were stratified into moderate cases or severe cases based on burning sensation before getting allocated to group I receiving Nigella sativa cream and group II receiving clobetasol propionate gel, two times a day for 45 days. Patients were examined every 15 days for a change in burning sensation and size of the lesion using the numeric pain rating scale (NRS) and a standard Vernier caliper, respectively. Statistical tests including Mann–Whitney U, Wilcoxon signed-rank, Friedman’s, Dunn’s post hoc, unpaired t, paired t, one-way repeated measures ANOVA, and Bonferroni’s post hoc were applied.

Results

There was a statistically significant reduction in the burning sensation as well as the size of the lesion in both groups (P ≤ 0.05). There was an 87.8% (moderate cases) and 85.7% (severe cases) reduction in the mean NRS scores on the 45th day in group I when compared to the 96.5% (moderate cases) and 93.48% (severe cases) in group II. There was a 92.9% (moderate cases) and 90.7% (severe cases) reduction in the size of the lesion in group I when compared to the 92.6% (moderate cases) and 93.1% (severe cases) in group II.

Conclusion

The topical application of Nigella sativa cream was effective and comparable to clobetasol propionate 0.05% gel in the management of OLP, without any side effects. Hence, this study recommends the use of topical Nigella sativa cream therapy in the management of OLP.

Clinical relevance

The current mainstay of treatment for OLP is the administration of topical or systemic corticosteroids, which are known to cause side effects, demanding a search for an alternative. Nigella sativa oil cream could be a safe, promising, cost-effective, adjunctive, or alternative modality.
Clinical trial registration number: CTRI/2020/07/026745 (India).
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Metadata
Title
Comparative evaluation of the efficacy of Nigella sativa (75% v/v) cream and clobetasol propionate (0.05% w/w) gel in oral lichen planus—a double-blinded randomized control trial
Authors
Lokesh Kumar S
Zameera Naik
Arun Panwar
Sridhar M
Vaishali Keluskar
Ram Surath Kumar
Publication date
22-12-2022
Publisher
Springer Berlin Heidelberg
Keyword
Lichen Planus
Published in
Oral and Maxillofacial Surgery / Issue 1/2024
Print ISSN: 1865-1550
Electronic ISSN: 1865-1569
DOI
https://doi.org/10.1007/s10006-022-01130-6

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